Statins at the Primary Care Level
EPRINA
An Educational Intervention to Improve Effectiveness in the Detection, Treatment and Control of Patients With High Cardiovascular Risk in Low-resource Settings in Argentina: Rationale and Study Design of a Cluster Randomized Controlled Trial.
1 other identifier
interventional
357
1 country
10
Brief Summary
Hypercholesterolemia, a major cause of disease burden in both the developed and developing world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%, whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was 37.3 % and the proportion of those who are under pharmacological treatment was dismally low: only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and low-dose aspirin were available free-of-charge at the primary care clinics of the public sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg) were incorporated into the package of drugs provided free-of-charge for patients with high cholesterol, according to CVD risk stratification. The goal of this study is to test whether a multifaceted educational intervention targeting physicians and pharmacist assistants, improves detection, treatment and control of hypercholesterolemia among uninsured patients with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will test whether a multifaceted educational intervention program lowers LDL-cholesterol levels and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance with clinical practice guidelines, and improves patient care management and adherence to medication. A cost-effectiveness study will be conducted to compare the intervention to the usual standard of care. This randomized cluster trial will enroll 350 patients from 10 public primary care clinics who will be assigned to receive either the intervention or the usual care. This study is timely and will generate urgently needed data on effective and, practical and sustainable intervention programs aimed at the prevention and control of CVD risk that can be directly used in other primary care settings and health care systems in LMICs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedAugust 16, 2017
August 1, 2017
2 years
January 26, 2015
August 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cholesterol Level
Net change in LDL-C levels from baseline to month 12 between intervention and usual care groups among all study participants.
1 year
Secondary Outcomes (5)
Global Cardiovascular Risk
1 year
Clinical practice guidelines compliance
1 year
Cholesterol reduction
1 year
Treatment compliance
1 year
Costs of the intervention
1 year
Other Outcomes (9)
Cholesterol Level stratified by history of diabetes
1 year
Global Cardiovascular Risk stratified by history of diabetes
1 year
Clinical practice guidelines compliance stratified by history of diabetes
1 year
- +6 more other outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALThe intervention group will receive a multifaceted educational intervention targeting physicians and pharmacist assistants to improve detection, treatment and control of hypercholesterolemia among uninsured patients with moderate-high cardiovascular risk in Argentina.
No Intervention Group
NO INTERVENTIONThis group will continue with the usual care. Irrespective of the assignment of the clinic to the intervention or control group, all physicians from participating PCCs have received previous training on global cardiovascular risk management, given by the Ministry of Health
Interventions
Physicians belonging to the PCC randomized to the intervention group receive a 3-component intervention: education workshop, Educational Outreach Visits and a mHealth application uploaded to their smartphones. In addition, 2 intervention support tools are used at the intervention clinics: 1. A web-based platform that is tailored to send SMS messages for lifestyle modification, and prompts and reminders for clinic appointments are used to improve medication adherence for patients. 2. On-site training to pharmacist assistants at the first EOV is given by physician trainers focused on counseling to improve medication adherence among patients initiating statin therapy and at each patient visit to the clinic to refill drug prescriptions.
Eligibility Criteria
You may qualify if:
- Arteriosclerotic cardiovascular disease: defined as acute coronary syndrome; history of myocardial infarction, stable or unstable angina, coronary revascularization, stroke, or transient ischemic attack presumed to be of atherosclerotic origin and revascularization.
- Moderate-High CVD risk according to the WHO charts adapted by the National MoH (estimated 10-year CVD risk ≥ 20%)
- LDL-C level ≥ 190 mg/dL
- Type 2 diabetes in patients between 40 and 75 years of age
You may not qualify if:
- Patients that are already receiving statins, pregnant women, bed-bound, and patients who cannot give informed consent.
- End stage chronics kidney disease receiving dialysis ,HIV/AIDS, tuberculosis, alcohol or drugs abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Centro de Atención Primaria de la Salud "Dr. Favaloro"
Puerto Madryn, Chubut Province, Argentina
Centro de Atención Primaria de la Salud "Ruca Calil"
Puerto Madryn, Chubut Province, Argentina
Centro de Atención Primaria de la Salud "Malvinas Argentinas"
Rawson, Chubut Province, Argentina
Centro de Atención Primaria de la Salud "Etcheparre"
Trelew, Chubut Province, Argentina
Hospital San Luis del Palmar
San Luis del Palmar, Corrientes Province, Argentina
Centro de Atención Primaria de la Salud N°11
Corrientes, 1034, Argentina
Centro de Atención Primaria de la Salud Dr. Balbastro
Corrientes, Argentina
Centro de Atención Primaria de la Salud N°13
Corrientes, Argentina
Centro de Atención Primaria "Jardín Residencial"
La Rioja, Argentina
Centro de Atención Primaria de la Salud "Faldeo del Velazco"
La Rioja, Argentina
Related Publications (2)
Gulayin PE, Lozada A, Beratarrechea A, Gutierrez L, Poggio R, Chaparro RM, Santero M, Masson W, Rubinstein A, Irazola V. An Educational Intervention to Improve Statin Use: Cluster RCT at the Primary Care Level in Argentina. Am J Prev Med. 2019 Jul;57(1):95-105. doi: 10.1016/j.amepre.2019.02.018. Epub 2019 May 23.
PMID: 31128958DERIVEDGulayin P, Irazola V, Lozada A, Chaparro M, Santero M, Gutierrez L, Poggio R, Beratarrechea A, Rubinstein A. Educational intervention to improve effectiveness in treatment and control of patients with high cardiovascular risk in low-resource settings in Argentina: study protocol of a cluster randomised controlled trial. BMJ Open. 2017 Jan 31;7(1):e014420. doi: 10.1136/bmjopen-2016-014420.
PMID: 28143840DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adolfo Rubinstein, MD, MSc, PhD
Institute for Clinical Effectiveness and Health Policy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2015
First Posted
March 5, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
August 16, 2017
Record last verified: 2017-08